Risk Factors for Barotrauma in COVID-19

NCT ID: NCT04859881

Last Updated: 2021-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

262 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-01-31

Brief Summary

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Barotrauma in mechanical ventilation (MV) is defined as lung damage attributable to the application of high airway pressure and is one of the potential mechanisms of ventilator-induced lung injury (VILI). Previous studies have shown an increased mortality in patients with barotrauma under MV; pneumothorax (PTX) being the most common presentation, but it can also present as pneumomediastinum (PM) with or without PTX, with extension to soft tissue as subcutaneous emphysema or even as pneumo-retroperitoneum and pneumo-scrotum.

Traditionally, underlying lung disease or age are known risk factors for non-trauma related barotrauma. However, in patients with novel coronavirus disease (COVID-19), the incidence of this complication is more common than in non-infected patients, as recently reported. Since little is known regarding which are the main risk factors for these events to develop, most pathophysiological mechanisms remain unexplained.

The aim of this study was to determine the risk factors for developing barotrauma in patients under MV with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS). Secondary objectives were to determine the incidence of barotrauma and its association with mortality.

Detailed Description

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Conditions

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Barotrauma Covid19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Barotrauma/cases

Cases were defined as patients with barotrauma consulted with the Surgery Department

No intervention

Intervention Type OTHER

No intervention

No braotruma/Controls

Controls were selected from a random sample of the COVID-19-ARDS cohort.

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients under MV fulfilling the Berlin definition for ARDS, with positive SARS-COV2 real time polymerase chain reaction

Exclusion Criteria

* Incomplete clinical records and other causes of extrapulmonary air
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Horacio Marquez-Gonzalez

UNKNOWN

Sponsor Role collaborator

Carlos Torruco-Sotelo

UNKNOWN

Sponsor Role collaborator

Sebastian Rodriguez-Llamazares

UNKNOWN

Sponsor Role collaborator

Hospital General Ajusco Medio

OTHER

Sponsor Role lead

Responsible Party

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Karla VerĂ³nica Chavez-Tostado

Head of Surgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital General Ajusco Medio

Mexico City, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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HGAM01

Identifier Type: -

Identifier Source: org_study_id

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